Gilead and Johnson & Johnson scored a double late last week after their triple HIV therapy Complera/Eviplera was approved for wider use on both sides of the Atlantic.
The FDA approved new labelling for Complera – a once-daily, single-tablet combination of Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) with J&J and Tibotec’s next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) Edurant (rilpivirine) – allowing the product to be used in a broader range of HIV-infected patients.
Complera was first launched in the US in August 2011 for treatment-naïve patients, but the new approval gives the go-ahead for patients to be switched to the drug from other treatment regimens.
Complera’s labelling now incorporates the results of the Phase III SPIRIT trial, which were reported last year and revealed that swapping HIV patients on a ritonavir-boosted protease inhibitor regimen to Gilead and J&J’s drug allowed them to maintain undetectable viral levels in the blood, whilst also improving blood lipid profiles.
Antiretroviral regimens containing boosted protease inhibitors are generally highly effective at suppressing HIV, but can also cause side effects including metabolic abnormalities that place patients at elevated risk of cardiovascular disease.
While the FDA updated the labelling of Complera early in 2013 to emphasise that the drug was only approved for use in treatment-naïve patients with low baseline viral load – as those with higher levels were more likely to experience treatment failure in clinical trials – the uptake of the product has been almost meteoric.
It has rapidly grown market share since to become the number two regimen not only in newly-treated HIV patients but also those who are switched from other treatment regimens, according to Gilead. All told, Complera/Eviplera achieved sales of $548 million in the first nine months of the year, a 144% increase on the same period of 2012, according to the drugmaker.
Meanwhile, in the EU – where it was approved as Eviplera in November 2011 – the product was recently granted regulatory approval for broader use, specifically in any HIV-infected adult patients without known mutations associated with resistance to NNRTI class, tenofovir or emtricitabine, and with a viral load of 100,000 copies/mL or less.
